Clinical Trials

Inclusion Criteria:

• Able to provide written informed consent (either from subject or subject's legally acceptable representative).
• Onset of jaundice within prior 8 weeks.
• Average daily consumption of > 40 (females) or > 60 (males) grams of alcohol for 6 months or longer, with < 8 weeks of abstinence before the onset of jaundice. Judgment
• regarding daily and long-term alcohol use and onset of jaundice will be made by the site investigator.
• Serum chemistry (as determined by local laboratory):
  • Serum total bilirubin > 3.0 mg/dL;
  • 50 < AST < 400 IU/L;
  • ALT < 400 IU/L;
  • AST/ALT > 1.5.
• Maddrey's discriminant function ≥ 32 assuming a control prothrombin time of 12 seconds.
• Model for End-stage Liver Disease (MELD) score: 21-30.
• When the diagnosis of AH remains in question, a liver biopsy (if clinically feasible and that subject has no contra-indications) will be required. Historical biopsy is allowed.
• Subjects must agree to use effective methods to prevent pregnancy while participating in the study.
• Subjects must agree to participate in an alcohol abstinence support program recommended by the local institution's addiction specialists

Exclusion Criteria:

• Subjects taking corticosteroids for a duration exceeding 7 days in the 30 days prior to screening.
• Subjects experiencing alcohol withdrawal symptoms or treatment with Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol.
• Active infection. Subjects who are febrile with leukocytosis are also excluded, even if there is no localizing diagnosis of infection.
• Serum creatinine > 2.5 mg/dL or eGFR < 60 mL/min/1.73 m^2.
• Subjects with acute kidney injury (AKl) or Hepatorenal syndrome.
• Subjects undergoing continuous veno-venous hemodialysis (CVVH).
• Uncontrolled active gastrointestinal bleeding.
• Refractory ascites.
• Liver biopsy (if carried out) with findings not compatible with AH.
• Stage ≥ 3 hepatic encephalopathy by West Haven criteria.
• Any severe concomitant cardiovascular, renal, endocrine, pulmonary, psychiatric disorder, or multi-organ failure.
• Other concomitant cause(s) of liver disease.
• Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years.
• Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and prescription medications.
• Existing or intended pregnancy or breast feeding.
• Participation in another interventional clinical trial within 30 days of Screening.
• History of organ transplantation, other than a corneal transplant.
• Underlying diseases that, in the opinion of the site investigator, might be complicated or exacerbated by proposed treatments or might confound assessment of study drug.

Eligibility last updated 10/10/22/22. Questions regarding updates should be directed to the study team contact.